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MICROSTAR Colposcope
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref U1C100A5Model C100A
by Ecleris
Identity
- Trade Name
- COLPOSCOPE EUDAMEDMICROSTAR Colposcope FDA UDI
- Generic Name
- Colposcope FDA UDI
- Device Name
- COLPOSCOPE EUDAMEDColposcope w/ Telescopic Stand & Inclined Binocular FDA UDI
- Model / Reference
- C100A EUDAMEDU1C100A5 EUDAMEDR00 FDA UDI
- Description
- Colposcope w/ Telescopic Stand & Inclined Binocular FDA UDI
Identifiers
- Catalog Number
- U1C100A5 FDA UDI
- Primary DI / UDI-DI
- B366U1C100A5R000 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B366U1COLPOSCOPESY9 EUDAMED
- Direct Marketing DI
- B366U1C100A5R000 EUDAMED
- FDA Product Code
- HEX FDA UDI
- EMDN Code
- Z12020703 COLPOSCOPES EUDAMED
- GMDN Term
- Colposcope FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 884.1630 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Colposcope
MICROSTAR Colposcope by Ecleris — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Colposcope.
- Bovie — BOVIE MEDICAL CORPORATION · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class II
- Gynex — GYNEX CORPORATION · Class II
- WALLACH — CooperSurgical, Inc. · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class II
- LEISEGANG — CooperSurgical, Inc. · Class II
- Galileo Colposcope, Direct Access — GYNEX CORPORATION · Class II
- ColpoStar™ 1H Colposcope — CooperSurgical, Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ecleris
Sources (2)
- FDA UDI 886c7d25-c812-45ef-82ac-c88166e62290 36 fields · synced Jun 19, 2026
- EUDAMED eb8776d7-ba73-4fa3-b91c-0e0ffb63ef2b 61 fields · synced Jun 19, 2026